Chapter 19
Point-of-care testing
James H. Nichols
Department of Pathology, Microbiology and Immunology, Vanderbilt University Medical Center, Nashville, TN, United States
Learning objectives
After reviewing this chapter, the reader should be able to:
G Define point-of-care testing (POCT).
G Identify the essentials of quality management for reliable
POCT results.
G Describe POCT limitations.
G List the resources available to assist staff in managing their
POCT program.
Introduction
Point-of-care testing (POCT) is laboratory testing con-
ducted close to the site of patient care. There are a num-
ber of portable POCT devices on the market, and the
available menu of analytes is extensive, including glu-
cose, urinalysis, pregnancy, occult blood, electrolytes,
blood gases, creatinine, urea, microalbumin, hemoglobin
A1c, drugs of abuse, therapeutic drug monitoring (lith-
ium), as well as testing for infectious diseases like strep-
tococcus, mononucleosis, influenza, and HIV. Even
coagulation testing [prothrombin/international normalized
ratio (INR)], enzymes [alanine aminotransferase (ALT)/
aspartate aminotransferase (AST)], and cardiac markers
[B-type natriuretic peptide (BNP)] are available on the
Clinical Laboratory Improvement Amendments of 1988
(CLIA) waived devices. CLIA waiver is granted to labo-
ratory tests that the US Food and Drug Administration
(FDA) and Centers for Disease Control and Prevention
(CDC) have determined to be so simple that there is little
risk of an erroneous result. CLIA waived tests have mini-
mum regulatory requirements, so a majority of POCT is
CLIA waived, allowing the test to be performed in a vari-
ety of settings by a diverse array of staff. However, as
with any test, POCT, even CLIA waived testing, has lim-
itations and poses risk of incorrect results and patient mis-
management if incorrectly performed or poorly managed.
POCT is also sometimes referred to as near-patient test-
ing, bedside testing, ancillary testing, and satellite testing,
because the POCT devices can be used in many different
Contemporary Practice in Clinical Chemistry. DOI: https://doi.org/10.1016/B978-0-12-815499-1.00019-3
© 2020 Elsevier Inc. All rights reserved.
patient-care settings: hospital acute and critical care units,
operating rooms, emergency departments, physician’s
offices, visiting nurses, patient home self-testing, ambu-
lances, and cruise ships. POCT devices have even trav-
eled on the space shuttle.
POCT has a number of advantages (Table 19.1) com-
pared with central laboratory testing. POCT devices use a
small volume of sample, and the sample does not need to
be processed. POCT is particularly useful in neonates,
small babies, and those with increased risk of blood loss
from phlebotomy. POCT devices can analyze whole blood,
urine, and other body fluids. Test results are rapidly avail-
able while the clinician is examining the patient. There is
no need to transport a specimen to a laboratory and wait
for results to come back. POCT thus works with the clini-
cal flow of patient care, because clinicians can order a test,
receive results, and institute clinical action in the same
visit. This provides the opportunity for faster therapeutic
intervention and potential for improved patient outcomes.
However, POCT has some disadvantages (Table 19.1)
as well. POCT is more expensive than traditional laboratory
testing, because POCT reagents are single-use tests, while
central laboratory reagents are packaged in bulk for high-
volume analysis. POCT in hospital settings is often not per-
formed by lab personnel, resulting in challenges in identify-
ing deviations in preanalytic, analytic, or postanalytic
components of testing. Documentation is an additional con-
cern, because POCT may be performed and results not
interfaced or documented in the patient’s electronic health
record. Clinical staff may be unfamiliar with the many laws
and compliance requirements that apply to laboratory opera-
tions both within the United States and internationally.
Quality point-of-care testing
Quality POCT is the delivery of results that are safe, reli-
able, and trustworthy for patient care. Quality implies the
appropriate use of technology to meet clinical needs. This
323
324 Contemporary Practice in Clinical Chemistry

TABLE 19.1 Point-of-care testing advantages and TABLE 19.2 Example point-of-care testing program for
disadvantages. an academic medical center.
Advantages Method Sites Devices Operators
G Immediate results—no lab transportation Glucose meters 53 213 4500
G Small blood volume
G Wide menu of tests available Hemoglobin A1c 10 21 50
G Whole blood, urine, and other body fluids analyzed without Fecal occult blood 38 1400
processing
G Works within clinical patient flow Gastric occult blood 6 500

Disadvantages Urine dipsticks 43 28 650

G More expensive than traditional laboratory tests Urine pregnancy 41 600
G Quality is questionable as anyone can run the analysis
Serum pregnancy 1 25
G Difficulties with regulatory compliance, billing, and
documentation Rapid strep 20 300
G Patient-focused staff with little formal education/experience
Mononucleosis 1 3
in laboratory testing
Influenza 14 225
pH paper 2 50
Blood gas portable 10 15 400
involves choosing the right method, POCT device or cen- Hemoglobin 3 4 50
tral laboratory analysis, to achieve the best outcome for a
Avoximeter 2 7 30
particular patient at a specific point in their pathway of
care. This might involve selecting between a glucose Prothrombin time/INR 7 7 60
meter, glucose on a blood gas analyzer, or glucose in a Activated clotting time 7 30 150
central laboratory, depending on the clinical situation. In Heparin management 1 3 6
addition, test results are legal documents and all of the
quality control (QC), training, instrument validation, trou- Basic metabolic panel 6 9 275
bleshooting, and other quality assurance practices and
documentation ultimately provide defensible evidence of
regulatory compliance should a test result ever come into
question. Above all, the reputation of the laboratory laboratories in Colorado and Ohio did not follow manu-
depends on the quality of its product, the test result. facturer’s instructions nor did they have package inserts
Unfortunately, there are a number of quality concerns available to staff performing the testing. Other laborato-
with POCT, which have been raised in the scientific liter- ries were cutting occult blood and urine dipsticks into
ature. Complaints about glucose meters for patient self- segments to save costs and extend their use. In an
testing, for instance, represent the largest number of expanded study conducted in eight states, 64% of labora-
complaints filed with the FDA for any medical device, tories (173/270) surveyed did not have manufacturer’s
with over 3200 incidents including 16 deaths [1]. POCT instructions or failed to follow the instructions [5].
devices can be reservoirs for nosocomial and antibiotic- Twenty percent of laboratories (n 5 53) were not perform-
resistant organisms in the hospital, and infections have ing QC as instructed, and 19% of laboratories (n 5 51)
been transmitted by poorly cleaned urinometers and blood did not provide training to staff or evaluate the staff’s
gas devices when carried between patient rooms [2]. ability to perform testing adequately.
Patients at nursing facilities in Mississippi, North POCT is a complex system. In a central laboratory,
Carolina, and California were diagnosed with hepatitis B there is one location and testing is limited to a few analy-
infection transmitted in association with blood glucose zers. Staff is also limited to a pool of medical technolo-
monitoring from shared spring-loaded lancets, glucose gists and medical laboratory scientists who have
meters, insulin vials, and poor hygiene between the significant training and skills in laboratory analysis. Staff
patients [3]. In a two-state pilot study conducted by the in a central laboratory has focused attention on testing.
Department of Health and Human Services (DHHS) on Their primary task is specimen analysis and producing
data from state laboratory inspectors, 77% of the 175,000 quality test results, without the distraction of patient care
CLIA enrolled laboratories had no direct oversight by responsibilities. POCT, on the other hand, is conducted at
someone with laboratory training [4]. Most of these labo- dozens of locations, with hundreds of devices and thou-
ratories were physician office practices, and 50% of sands of operators (Table 19.2). Getting all operators to

perform a test consistently, in the same way every time, is
difficult. POCT is performed by clinical staff whose pri-
mary focus is patient care. Nurses and physicians are only
secondarily focused on performing the necessary steps for
QC, calibration, maintenance, cleaning, and quality assur-
ance of POCT devices. There is the assumption that if a
POCT device generates a result, then that result must be
correct; otherwise, the device would not have generated a
value. However, there are many factors that can affect the
quality of the POCT results.
The DHHS studies from state inspectors uncovered
quality concerns with the performance and staff training
in a significant percentage of sites performing POCT,
mostly physician offices [4,5]. Most physicians and facili-
ties were eager to change once the issues were brought to
their attention but had no resources or background to
design the training and ongoing quality assurance pro-
gram. Laboratory professional consultation was needed to
improve the regulatory compliance of these sites and
guarantee the quality of POCT results. For many hospitals
and health systems, this consultation is available through
a medical technologist who specializes in POCT quality
assurance, called the “point-of-care coordinator.” The
point-of-care coordinator is the laboratory liaison to the
nursing unit to assist with operator training, instrument
validation, documentation, and quality improvement. For
some health systems, the point-of-care coordinator is
extended to physician office laboratories and home nurs-
ing networks under the health system umbrella, whereas
other private physician offices hire pathologists, doctoral-
level laboratory directors, or point-of-care coordinators as
paid consultants to assist with their POCT regulatory
compliance. The point-of-care coordinator is thus a spe-
cialized medical technologist who has the additional regu-
latory knowledge, communication, and management skills
to help POCT sites improve the quality of their testing
and meet regulatory guidelines.
Point-of-care testing regulations
The challenge of managing POCT is the complexity of
ensuring regulatory compliance at dozens of sites, with
hundreds of devices and thousands of operators. Each site
must supervise equipment, personnel, and safety practices
comparable with performing the testing at a single labora-
tory location; therefore POCT multiplies the many labora-
tory issues, like validation and monitoring of devices,
reagent lots, expiration dates, and temperatures across
dozens of sites. Inspectors use the phrase “site neutral” to
describe the test requirements that are independent of
where the test is conducted, and POCT sites are treated
like independent laboratories regardless of location.
The quality of POCT, like other laboratory tests, is
regulated by the federal CLIA law and inspected through
Point-of-care testing Chapter | 19 325
centers for medicare and medicaid services (CMS) and
the state departments of public health. CLIA sets the min-
imum requirements for laboratory testing based on the
complexity of analysis, instrument maintenance, and
result interpretation. Tests are categorized as waived,
moderate, or high complexity with increasingly higher
levels of requirements for operator education, training,
method validation and quality documentation. The Joint
Commission, the College of American Pathologists
(CAP), and the Commission on Office Laboratory
Accreditation are private accreditation agencies that are
deemed under CLIA to inspect and accredit labs that meet
the minimum CLIA standards in addition to their individ-
ual agency recommendations. Although each of the
accreditation agencies varies in the details and stringency
of their recommendations, all of the agencies require
some level of equipment validation before use of the test
on patients, written procedures, operator training and
competency on the specific test, as well as ongoing man-
agement of patient results (with appropriate normal refer-
ence ranges or interpretive comments) and safe handling
and disposal of biohazardous patient specimens. CLIA
compliance is enforced by blocking Medicare and
Medicaid payments for noncompliant laboratories and
levying fines against the organization and laboratory
director, while accreditation agencies can pull a labora-
tory’s accreditation, institute fines, and publicize citations
for laboratories with quality concerns. Despite the sale of
many POCT devices in local grocery stores and pharma-
cies, a physician cannot simply walk into a store, pur-
chase a device, and start testing patients without first
ensuring licensure of the site performing testing and docu-
mentation of quality assurance for regulatory compliance.
POCT regulations cover laboratory testing conducted
for patient care decisions and medical management. The
portability and ease of use of POCT devices make them
convenient for use in research protocols; however,
research testing is exempt from the CLIA regulations, but
only if no patient care decisions are made from the test
results. Staff should be warned that the CLIA guidelines
still apply to the use of a POCT device as part of a
research protocol if a medical decision is made or patient
care is changed based on the test result. For example, the
use of a pregnancy test to determine whether a patient can
enroll in a research study and potentially receive a study
drug is a medical, patient care decision, so all of the
CLIA and accreditation guidelines would apply to the
pregnancy test. Alternatively, if the pregnancy test was
performed as part of the study and none of the test results
were communicated to anyone caring for the patient, no
change in medical management could occur based on the
test. This testing would be considered purely research.
When results are recorded in a log to be reviewed after
the study completion, the results cannot be utilized for
326 Contemporary Practice in Clinical Chemistry
patient care and the test is classified as research; thus
CLIA does not apply in this case. A good rule of thumb
to determine if the regulations apply is to answer the
question, “Will a change in treatment or management
occur based on the result of this point-of-care test?” For
the pregnancy test, a decision may be made to include the
subject in the study if the test is negative and to exclude
the subject if the test is positive. This constitutes medical
management, in which a clinical decision (to enroll in the
study) is made based on a test result. CLIA regulations
therefore apply in this case, but do not apply when the
test results are protected in such a way as to prevent
the use of the result by any clinicians actively caring for
the patient.
Documentation is fundamental to all of the accredita-
tion requirements, and data records and logs are consid-
ered the supporting documentation for regulatory
compliance. Some devices provide automated electronic
capture of the necessary data (patient and operator identi-
fication, date, time, device serial number, reagent lot
number, expiration dates, etc.) at the time of analysis.
However, over 50% of POCT devices are manual, visu-
ally interpreted dipsticks and kits that require handwritten
records or manual input into an electronic medical record.
This has led to an increase in the utilization of automated
readers for manual dipsticks and lateral flow tests that can
automate the interpretation of results and be interfaced
with the patient’s electronic medical record. The amount
of data requiring review from POCT can be overwhelm-
ing, and computerized POCT data management can assist
personnel in regulatory compliance, billing, and review of
data for quality improvement. Point-of-care coordinators
can assist personnel with interpretation of the regulatory
guidelines, development of a quality program, and prepa-
ration and review of the necessary documentation to meet
the specific accreditation guidelines. Some laboratories
may be accredited by multiple agencies and must prepare
documentation to support inspection against multiple sets
of recommendations. Federal agencies like CLIA may
deem equivalence to another agency with stricter recom-
mendations such as New York State, the Joint
Commission, or CAP, for instance. Agencies are continu-
ously updating their recommendations, so point-of-care
coordinators and staff must keep current on the most
recent changes that may affect their POCT operations.
Point-of-care testing connectivity and
interfacing
Computerized data management automates the collection
and review of the volumes of data acquired by POCT.
Newer POCT devices have computerization that ensures
regulatory compliance by collecting pertinent information
at the time of testing and prompting the operator through
the correct sequence of steps to perform the test consis-
tently. Data stored within the device can be downloaded
to a computer database or POCT data manager, by plac-
ing the device into a docking station that connects to the
Internet, via modem, or wirelessly to a remote POCT data
manager. The POCT data manager can also interface with
a laboratory information system (LIS) and a clinical data
repository (CDR), such as a hospital information system
(HIS) or electronic patient medical record, and other clini-
cal information system (CIS) for permanent storage of the
test results.
The POCT data manager has multiple functions. The
data manager communicates bidirectionally with devices.
From the device, the data manager collects test informa-
tion and associated date, time, patient identification (ID),
operator ID, lot and serial number fields, as well as any
associated result flags and comments. The data manager
can also send current lists of competent operators and
update any reagent and control lots, expiration dates, and
other information to the device remotely. The data man-
ager acquires control results to document successful per-
formance of QC at the required frequency of testing, as
well as any corrective actions for failed QC. POCT data
managers use patient identification to search against
active patients in the hospital or LIS to transfer patient
results to those systems for permanent storage. Newer
POCT devices have the capability of positive patient iden-
tification. These devices acquire admissions/discharge/
transfer information on patients through the data manager
and can display the patient’s name on the POCT device
before analysis. The operator then confirms the patient
identification by entering a second patient identifier (like
birth date) before the device will allow testing. Positive
patient identification reduces the chance of ID entry errors
that can prevent results from being transferred to the cor-
rect patient’s medical record. The data manager thus acts
as a central processor for information coming from POCT
devices to the patient’s medical record and for informa-
tion required by a device for continued operation. POCT
data managers automate the review of data and reduce the
amount of labor required to manage POCT operations.
Historically, each manufacturer developed their data
manager systems in isolation, meaning that different
POCT devices required different physical cables to con-
nect to the same data manager, and even language and
communication protocols for data were not shared
between different devices and manufacturers. This com-
plicated and significantly increased the cost of imple-
menting and changing devices because of the need to
purchase additional computer systems and interfaces to
accommodate the data transfer. The lack of common com-
munication standards led to the development of the
POCT1 standard for point-of-care connectivity by the
 Point-of-care testing Chapter | 19 327

FIGURE 19.1 The POCT1 device connectivity standard describes two interfaces. The device interface allows bidirectional communication between
the point-of-care testing devices and the point-of care data managers through docking station access points using the Internet, wireless, or serial com-
munication. The observation reporting interface is an electronic data interface that transfers patient test results and order information between the
point-of-care data managers and the laboratory information system, clinical data repository (an electronic medical record), or other clinical information
system. Reproduced with permission from Clinical Laboratory Standards Institute. Point-of-Care Connectivity: Approved Standard POCT1-A2. CLSI,
Wayne, PA, 2006, p. 306.

Clinical and Laboratory Standards Institute (CLSI) [6].
POCT1 was developed by a group of vendors, consumers,
and government representatives to enable the seamless
information exchange between POCT devices, electronic
medical records, and LIS. This standard defines the physi-
cal connections as well as the communication protocols
for data transfer between the POCT devices and the data
managers (the device interface), as well as between data
managers, and the LIS, CDR, or CIS through the elec-
tronic data interface (Fig. 19.1). The POCT1 standard is
based on the Institute of Electrical and Electronics
Engineers and Health Level Seven standards for medical
information transfer, and representatives from these
groups worked with CLSI in the development process.
There are currently many devices that comply with the
POCT1 standard, and several POCT data manager sys-
tems currently use this standard to connect to multiple
POCT devices.
Point-of-care testing quality assurance
programs
Compliance with regulatory guidelines requires an under-
standing of the regulations, good communication among
all the staff involved in POCT, organization, and plan-
ning. The formation of a POCT committee, an interdisci-
plinary committee to oversee POCT approvals and quality
concerns, can assist in the development of a quality assur-
ance program and provide a discussion forum for issues
as they arise. It is important to have representation from
all groups involved in POCT. Administration, laboratory,
nursing, and physicians are key individuals to have on the
POCT committee, but representation from purchasing,
distribution, pharmacy, and nutritional services may
also be important when specific issues arise. POCT
committees develop high-level policies that can cross
departmental and institutional boundaries in hospitals and
health systems with departmental or multihospital admin-
istration silos.
A key function of the POCT committee is to review
and approve requests for new tests and to address compli-
ance concerns with existing testing. Due to its interdisci-
plinary composition, the committee can balance opinions,
depersonalize judgments, and deflect the political heat
that may arise from decisions to remove testing or decline
the implementation of new testing on specific nursing
units or locations. The committee can take the blame for
a decision rather than an individual like the POCT coordi-
nator or laboratory director. Representation from purchas-
ing and distribution can alert the committee to requests
for tests outside of the committee approval process if staff
try to go around the committee. Other ancillary staff, like
nutritionists who may change diet based on glucose or
electrolyte test results, may also be useful to have repre-
sented on the POCT committee.
Pharmacists are becoming more involved in POCT,
not just because of drug dosing based on POCT results,
but because pharmacies are now stocking POCT devices
and pharmacists in some hospitals are starting to perform
POCT as an alternative to nursing staff. Pharmacy-based
clinics, in Britain and America, such as minute clinics
and urgent care centers, are starting to offer POCT as part
of a rapid care pathway designed to facilitate same day
visits when patients cannot get a same-day appointment
with their primary care physician. Patients are often seen
by nurse practitioners, and POCT is offered to make a
diagnosis (like rapid strep testing) and get treatment (such
as an antibiotic prescription) in the same visit. POCT in
these clinics is conducted at the request of the clinician or
pharmacist, but in some locations, patients can even order
their own tests and have them conducted by the
328 Contemporary Practice in Clinical Chemistry
pharmacist (direct-access testing). Pharmacists, because
of their training and experience with POCT, can provide a
quality result that can be trusted more than patient self-
testing at home, and pharmacy testing may be more con-
venient for patients than having to wait to schedule a phy-
sician visit, get a test order, travel to a phlebotomy station
that will then transport a specimen to a central laboratory,
and further wait for a test result to be communicated back
to the physician where a call can be made to the patient
to institute treatment. Think of the urine pregnancy test: if
the patient performs the test at home, they must then go
to a physician for repeat testing by a central laboratory to
verify a positive result. Visiting a pharmacy creates a reli-
able test result that can be trusted for ongoing care,
because the pharmacy must follow laboratory quality reg-
ulations when performing POCT compared with home
self-testing, which has no quality requirements.
A POCT quality assurance program encompasses all
of the device standardization, validation, training, compe-
tency, and operational aspects of performing POCT.
POCT should be considered a part of patient care within
the institution rather than an ancillary laboratory service,
so POCT should be incorporated into the overall institu-
tional quality improvement plan. Quantitative measures of
POCT performance, such as compliance errors with moni-
toring temperatures, failure to recognize reagent expira-
tions, or corrective actions after control failure, can be
tracked and sorted by site to determine persistent pro-
blems and trends (Table 19.3). Nursing units and sites
TABLE 19.3 List of possible quality improvement
performance monitors for point-of-care testing.
Successful QC
G QC documentation
G Number of errors where wrong QC analyzed (e.g., high
control analyzed as low)
G Percentage of QC that fail
G QC outliers with comment
G Failed QC with appropriate action (patients not tested)
Utilization (number of tests per site or device)
G Tests billed versus tests purchased
G Single lots of test and QC in use at any time
Compliance
G Untrained operators performing testing
G Clerical errors or data entry errors during testing or result
reporting
G Medical record has results reported with reference ranges
G Expired reagents and QC/reagent bottles and kits dated
appropriately
G Refrigerator temperature monitored
G Proficiency testing successful
G Action plan in response to site compliance deficiencies
with recurrent quality issues should implement additional
follow-up, closer supervision, or other actions to improve
performance. Accreditation inspectors like to see trend
graphs, demonstrating the identification of a problem,
intervention, and improvement of performance over time.
Accreditation agencies used to schedule periodic inspec-
tions with advance notification; however, the Joint
Commission and CAP now utilize unannounced inspec-
tions. Staff must always be ready for an inspection and
will no longer have time to prepare records and quality
documentation in advance. Use of quantitative perfor-
mance monitors and integration of the POCT program
into the institution quality improvement plan are a good
means of identifying and continuously improving on pro-
gram weaknesses. Development of an individual quality
control plan (IQCP) can identify risk of errors and define
a quality assessment for tracking ongoing performance.
Baseline performance assessment and monitoring trends
of improvement over time also provide excellent docu-
mentation whenever a POCT result is questioned, regard-
less of who questions a result—a clinician, a patient, a
staff member, or an outside inspector.
Interdisciplinary communication
The management of POCT requires the development of a
quality assurance program and clear communication of
that program to everyone involved. The objectives of
improved patient care through POCT and the path to
achieving this goal need to be clearly defined. Likewise,
the fundamentals of regulatory compliance and quality
improvement must also be spelled out. Unfortunately,
clinicians perceive POCT from a different perspective
than the laboratory. Technology and nursing has a kind of
“love hate” relationship. Taking the optimistic view,
technology is intricately linked to the science of nursing
and physician practice. POCT provides more rapid clini-
cal decision-making, moving patients through the system
(the hospital or physician’s office) more quickly; improv-
ing the efficiency of delivering care; and decreasing
patient wait times. However, from the pessimistic view-
point, technology detracts from the art of nursing and
does not integrate well into the daily patient care respon-
sibilities. Compliance with regulatory demands and qual-
ity assurance protocols is time- and labor-intensive for
clinical staff and takes the focus of nurses and physicians
away from the patient. Physicians are also experiencing
increased pressure to examine more patients while con-
ducting successful research programs, maintaining resi-
dent education, and developing unique programs in their
discipline for academic advancement. Nurses are encoun-
tering increasing pressure to cross-train and diversify,
take on more roles, multitask, and increase the use of
unlicensed personnel for some aspects of patient care.

Nurses and physicians must be responsible for the physi-
cal, emotional, and spiritual care of the patient. These car-
ing and nurturing roles are in direct contrast to the
scientific rigors of the laboratory that include accuracy,
precision, and quality focus.
Successful POCT management requires an apprecia-
tion of different viewpoints, mutual respect, and compro-
mise. There are always multiple ways to achieve a goal.
Conflict with POCT frequently arises from the laboratory,
dictating how clinicians should act in response to a prob-
lem without considering all perspectives. As compliance
issues or other differences of opinion arise, participants
need to look beyond the paradigms of their discipline and
think outside the box. In any field, there are shared sets of
assumptions or paradigms. Paradigms determine what is
taught, the methods, and how findings are interpreted.
Nursing has one set of paradigms, the laboratory has
another, and physicians have a third set of paradigms.
When a compliance issue is noted, like an unapproved
POCT device, the laboratory may interpret this as a will-
ful breach of policies and failure to go through the POCT
committee approval process. However, the physicians
may perceive this only as an attempt to improve the care
of their patients and improve turnaround time of results.
They may not be aware of the stringency of laboratory
regulations and the need for committee approval or device
validation before using a POCT device. Nursing, on the
other hand, was conducting the test, because the physician
ordered it and was only following instructions. The prob-
lem here is a lack of understanding about the regulations
governing POCT and a failure to communicate effectively
the issues. A clear discussion of the POCT committee pol-
icies and the reasoning behind the policies will be more
successful than dictating compliance. When staff under-
stand why they must follow policies, they will be more
likely to comply with QC performance, refrigerator tem-
perature monitoring, and seeking approval before purchas-
ing new POCT devices.
Self-management
POCT is a decentralized process, and the laboratory can-
not be at every site 24 hours a day to monitor test perfor-
mance. The laboratory has to delegate responsibility for
POCT to the clinical staff and trust that nursing and phy-
sicians will properly manage the testing process. In this
model, the laboratory takes a central oversight role for
POCT, but the clinical staff takes responsibility for the
day-to-day operations such as purchasing reagents, dis-
carding outdated tests, validating staff competencies, and
performing QC and other functions needed to maintain
testing on the medical unit. This laboratory clinical part-
nership is based on mutual respect and shared responsibil-
ity for POCT quality.
Point-of-care testing Chapter | 19 329
Successful POCT is based on self-management.
Clinical units make a decision that faster testing will
improve patient care and must allocate the resources nec-
essary to support the testing, while the laboratory provides
all of the policies, procedures, and information required
for the staff to succeed and continuously improve their
performance. One means of distributing POCT informa-
tion to many sites within an institution is through a dedi-
cated website for POCT. A website is easily accessible
from anywhere within a health system with only a com-
puter, web browser, and internet connection. An institu-
tional POCT website may contain contact information for
the lab director, point-of-care coordinator, and support
staff as well as training checklists, policies and proce-
dures, compliance reports, minutes of the POCT commit-
tee, current POCT projects, and links to the FDA
laboratory safety tips or current CAP/Joint Commission
accreditation checklists. A website could also contain a
list of POCT contacts on each of the clinical units and fre-
quently asked questions written in a language that the
clinical staff can understand and relate. The website could
contain compliance trends by unit of their performance
monitors, so units can compare their performance to
others and help prioritize their action plans. Self-
management encourages clinical staff to take charge of
their own testing.
Many institutions have adopted electronic document
control systems that can be an alternative to creating a
dedicated POCT website. Electronic document control
systems allow the procedures to be available on the nurs-
ing units from any of the clinical workstation computers,
so staff does not have to hunt for a hardcopy of a proce-
dure when conducting testing. Electronic document sys-
tems remind staff for required annual review of policies
and provide an easy means of distributing policy revisions
to all the sites performing POCT simultaneously. Most
importantly, POCT policies and procedures can be inte-
grated with other nursing policies in format and wording,
emphasizing the role of POCT in patient care rather than
as a “laboratory” service.
Institutions with a large number of staff have also
adopted electronic training and competency systems.
These programs can track operator competency and send
messages to those pending expiration of their training.
Training/competency systems can utilize slides, video
with sound, exams, and other tools to refresh staff on key
points to remember when performing POCT and ensure
that these points were received and understood. CLIA and
accreditation agencies require six elements of competency
to be evaluated annually including:
1. Direct observation of routine test performance
2. Monitoring the recording and reporting of test results
(including critical results)
330 Contemporary Practice in Clinical Chemistry
3. Review of intermediate test results, worksheets, QC
records, proficiency test results, and preventive main-
tenance records
4. Direct observation of preventive maintenance and
function check performance
5. Assessment of test performance using previously ana-
lyzed specimens or proficiency testing samples
6. Assessment of problem-solving skills
Many of these elements can be assessed through an
electronic training/competency system with an exam that
includes troubleshooting questions, but direct observation
of test performance and comparison of test results
requires one-on-one time of a staff trainer with each
POCT operator. Observing test performance cannot be
automated through an electronic training system.
Staff members who perform testing are wholly respon-
sible for their success as well as their failure. By position-
ing the laboratory as a resource for POCT and distancing
the laboratory from the performance aspects of the POCT
program, staff members tend to help each other, commu-
nicate more about their issues, and work more as a team
than when the laboratory is mandating compliance and
dictating practice. Each unit can find unique solutions to
issues that work best within the unit’s workflow. Issues
are brought to staff attention by the laboratory and staff is
encouraged to inspect their own practice and determine
the solution that operationally works best for them. For
instance, two levels of QC must be analyzed each day of
testing, but this can be accomplished in a number of
ways. Nursing units should rotate the responsibility
among different staff, but a nursing unit might choose to
have the first shift run QC, because it works better into
their patient rounds, while another unit might find that
night shift works best when staff are not as busy. By facil-
itating communication between the POCT sites and the
encouraging staff to solve their own problems in a regula-
tory compliant manner, the laboratory becomes a resource
of information to help staff improve their own program.
Staff can then find the best ways to integrate POCT into
their current workflow without the laboratory interfering.
This improves interdisciplinary relations between the clin-
ical sites and the laboratory and promotes collegiality
rather than animosity.
There are many POCT resources that are available to
assist staff with managing POCT. A journal, Point of
Care: The Journal of Near-Patient Testing & Technology
(www.poctjournal.com), is dedicated to basic research,
method validation data, regulations, and other topics
related to POCT management and device technology. The
Journal of Analytical Laboratory Medicine also publishes
peer-reviewed research and offers case studies, focused
studies, and laboratory reflections involving POCT.
Several textbooks are also devoted to POCT [7,8], and the
American Association for Clinical Chemistry (AACC)
has a community forum, the AACC Artery, to discuss
POCT issues (www.aacc.org/community/forums). AACC
also offers a POC Bootcamp and certification program for
coordinators who are managing POCT programs. There
are also a number of regional point-of-care coordinator
groups throughout the country, and their meetings, activi-
ties, and original articles are available on a POCT website
(www.pointofcare.net). Point-of-care coordinators and
staff involved in POCT thus have a variety of resources
and ways to contact others involved in POCT to get
answers to their questions, seek advice, and get feedback
from staff who are experiencing similar challenges.
Analytical performance
Although regulatory compliance and management is a sig-
nificant aspect of POCT, the analytical performance of
devices also contributes to the overall quality of results
and clinical applicability of a test. Poor testing will result
when staff fail to follow manufacturer’s instructions on a
device with excellent analytical performance; it is the
same as if staff do everything right, but picks a device
with poor analytical performance. Technical performance
and management practices both contribute to quality
POCT. Therefore institutions must be concerned about
picking the right test for the specific patient as well as
ensuring that the test is conducted properly, and QC and
quality assurance practices are followed.
The required performance characteristics of a device
must match the clinical need of the patient and the ques-
tion being asked by the physician. POCT devices are dif-
ferent methods than core laboratory instrumentation. Each
method has unique bias, imprecision, and analytical inter-
ferences that may limit its clinical utility. Glucose meters,
for instance, have greater imprecision and are susceptible
to different interferences than central laboratory methods.
Despite recommendations by the American Diabetes
Association for agreement of glucose meters within 5% of
a central laboratory method, none of the currently mar-
keted glucose meters can meet these performance stan-
dards [9]. Glucose meters are thus not recommended for
use in screening or diagnosis of diabetes [10,11]. The var-
iability of glucose meters limits their use to management
of patients already diagnosed with diabetes. CLSI recom-
mends that glucose meters agree with a comparative cen-
tral laboratory method within 6 12 mg/dL for results
,100 mg/dL and 6 12.5% for results $ 100 mg/dL [12].
Glucose meters are too variable for use in analyzing spe-
cimens collected after a glucose tolerance test for diagno-
sis of diabetes, and meter variability also limits the utility
of meters in health fair and shopping mall screening pro-
grams. Device performance requirements can change with

the concentration of analyte and the clinical application
(screening, diagnosis, or management).
Operators are a key part of device performance, and
there are several studies indicating poorer performance by
staff without laboratory training than operators with train-
ing. The CDC compared performance on proficiency test-
ing samples sent to laboratories performing POCT [13].
Proficiency samples are specimens of unknown concen-
tration analyzed like patient specimens where the results
are graded and compared with all other laboratories per-
forming the same test. The CDC noted significantly better
performance on proficiency samples for medical technolo-
gists working in accredited hospital laboratories than non-
laboratory staff performing testing in physician office
laboratories. Intermediary performance was seen at those
sites performing testing with laboratory-trained operators.
Training improves performance, and the Oregon Health
Sciences University noted significant improvement in
both the performance of glucose testing and interpretation
of results after a standardized training program [14].
Performance not only improved immediately after training
but continued to improve consistently for the following
several months that were monitored by the study.
Operators and the training of operators can thus affect the
quality of POCT results as well as the interpretation and
treatment decisions based on POCT results.
Standardization is an important aspect of successful
POCT programs. Selecting one manufacturer for glucose
meters and one kit for pregnancy testing simplifies quality
management. With dozens of POCT sites and thousands
of operators, increasing the number of different devices
complicates the ability to manage the program and stres-
ses available staff and resources. Validation, procedures,
and training are required for each device for regulatory
compliance. CAP also requires subscription to a
proficiency-testing program. As the number of different
devices multiplies, there are more procedures and training
to maintain, and staff who rotate or test patients infre-
quently may not remember how to operate the test when
required. For POCT, simplicity is fundamental. Fewer
devices, limited testing sites, and reducing the number of
operators simplify the management of testing and enhance
compliance. With fewer devices and a smaller group of
key POCT operators, it is easier to train staff and more
economical to manage the program.
Method limitations
POCT methods are different from clinical laboratory
methods and have their own biases and interferences.
Clinical treatment protocols and pathways of care based
on central laboratory methods may not necessarily be
transferable to the same patient populations when using
POCT results. As noted already, glucose meters may
Point-of-care testing Chapter | 19 331
provide a faster glucose measurement, but the variability
of the method may not allow the device to be used for
diagnosis or screening of general patients, while central
laboratory glucose results can be utilized for these situa-
tions. This is why clinical validation of a device on the
intended population using routine staff operators at that
location is so important before implementation of a test
for patient care.
POCT devices are portable, so reagents and test strips
may be exposed to varying environmental conditions
compared with testing in a well-controlled laboratory.
Visiting nurses travel to patient’s homes, and tests can be
exposed to cold in the winter and heat in the summer.
Humidity can damage colorimetric test strips, like urine
dipsticks. Altitude may also affect some tests that are sen-
sitive to oxygen, like glucose and blood gas tests. Storage
and environmental conditions are factors that need to be
controlled to ensure quality test results. Tests and devices
should be removed from vehicles when not in use to pre-
vent freezing and overheating. Strip vials also need to be
tightly recapped and tests stored in cool, dry places away
from radiators and windows where the tests may be dam-
aged from heat, light, and moisture.
Drugs, disease metabolites, and diet can affect POCT
results in different ways compared with traditional labora-
tory methods. Some glucose strips are sensitive to salicy-
late, acetaminophen, and urea. Vitamin C in high doses
can act as an electron carrier in POCT glucose reactions.
Dietary constituents affect other POCT methods. Meat
and peroxidase-containing vegetables, for instance, may
give false-positive reactions in guaiac-based occult blood
tests. Hydration status and drinking excess water can
dilute urine, generating false-negative drug and pregnancy
tests. Hemolysis of blood elevates potassium levels and
may not be detected in a whole blood sample used for
POCT compared with serum with laboratory analysis
where hemolysis is evident as red color in the sample; so
hemolysis can be overlooked with POCT, leading to
falsely increased potassium results and the potential for
misinterpretation and inappropriate clinical management.
Critical illness is another factor to consider with
POCT. Patients presenting with extremes of physiology
challenge the performance of POCT devices. Glucose
meters originally developed for use in patient self-testing
may perform differently when used in a hospital environ-
ment. Diabetic outpatients are ambulant and generally
healthy compared with critical inpatients on oxygen ther-
apy and various medications. Critically ill patients also
have low hematocrits that can interfere with glucose
methodologies. Manufacturers have been encouraged by
the FDA to include a limitation in the meter package
insert that “the performance of the test system has not
been evaluated in the critically ill.” While newer meters
have received FDA approval for use in critically ill
332 Contemporary Practice in Clinical Chemistry
populations, consumers are still warned of interferences
with meter results when utilizing capillary fingerstick
samples in patients with poor peripheral circulation. This
limitation warns the consumer of the potential for interfer-
ence in subpopulations of the critically ill that may show
variations in results with certain sample types and condi-
tions. Consumers should restrict use of glucose meters in
order to adhere to package insert limitations, such as
acceptable hematocrit and oxygen ranges, and prohibit
use of capillary fingerstick samples from patients with
poor peripheral circulation (i.e., diabetic ketoacidosis,
nonketotic/hyperosmolar conditions, congestive heart fail-
ure stage IV, shock, and peripheral vascular disease)
[15,16]. Blood can pool in the periphery and capillary
samples in such patients may not reflect the physiology of
central circulation. Currently, only one glucose meter has
been FDA-cleared for use in critically ill patients using
capillary fingerstick samples, but the analytical perfor-
mance of this meter is significantly more variable than
laboratory methods. Clinicians are cautioned to interpret
POCT results with care in patients with rapidly changing
physiologic conditions, particularly when analyzing capil-
lary samples in critically ill patients despite FDA approval
for use in these populations.
Use of venous or arterial samples may be a more
acceptable alternative in patients with poor peripheral cir-
culation, and capillary sampling is affected. Alternatively,
hospitals may choose to use a different glucose methodol-
ogy such as a blood gas analyzer or send a sample to the
central laboratory [15]. However, delays in test turn-
around may prohibit sending a sample to a central labora-
tory. Hospitals can also choose to use a glucose meter
off-label by analyzing capillary samples despite the manu-
facturer warnings for critically ill patients. Caution should
be taken, however, since off-label use shifts the CLIA-
waived glucose meter to a high-complexity category
requiring additional validation and documentation. CLIA
high-complexity may further limit the staff who can per-
form testing, as hospitals frequently use patient care assis-
tants, staff with only a high school education and on the
job training, to perform glucose testing [15,17]. Under
CLIA high complexity, staff with only a high school
diploma would not be eligible to conduct glucose meter
testing, and more advanced clinical staff, such as regis-
tered nurses or nurse practitioners, with additional labora-
tory training, experience, and licensure (in some states)
may be required.
POCT employs unprocessed specimens. Whole blood
is analyzed on POCT devices, whereas most laboratory
methods require serum or plasma. Glucose, however, is
unstable in whole blood. The specimen must be analyzed
quickly after collection, or inhibitors of cellular glycoly-
sis, like fluoride or oxalate, must be added to stabilize the
glucose levels in the sample. Specimen additives, like
fluoride and oxalate, can interfere with some POCT meth-
ods, so correlations of glucose meters against laboratory
methods must quickly analyze a whole blood specimen on
the glucose meter and either simultaneously collect a sep-
arate sample for laboratory analysis, or centrifuge and
separate the remainder of the POCT specimen. Once sep-
arated from cells, glucose is stable in plasma/serum for
several days refrigerated and longer if frozen. While use
of whole blood for POCT and serum/plasma for labora-
tory analysis ensures appropriate specimen types for each
methodology, the glucose concentration may not match
between the two methods because of physiologic differ-
ences between whole blood and serum/plasma (Fig. 19.2).
Glucose distributes within the aqueous portion of
blood. Since there is less water inside erythrocytes (73%
water/27% lipids and protein) compared with the plasma
portion of blood (93% water/7% lipids and protein), the
glucose concentration will be lower inside red blood cells
than plasma from the same patient specimen. The actual
difference will depend on the hematocrit (concentration
of erythrocytes in a sample). At a normal hematocrit of
45%, plasma is B11% higher than whole blood. Patients
with higher hematocrits will have greater difference
between whole blood and plasma/serum glucose, while
patients with lower hematocrits will have less difference.
Method comparisons and validation of POCT devices
must take into account these physiologic differences in
specimen matrix when interpreting the agreement between
different methods. To simplify interpretation, most
FIGURE 19.2 Whole blood to plasma differences. The physiologic
water content in whole blood is a mixture of the plasma and erythrocyte
red blood cell water and varies with the hematocrit or volume of red
blood cells in blood. Analytes that follow water, like glucose, electro-
lytes, and some drugs, will show similar differences in concentration
when measured in whole blood versus plasma.

manufacturers calibrate their glucose meters to read a
plasma equivalent result despite accepting whole blood
samples. Glucose meters should theoretically be compara-
ble with central laboratory methods in patients with nor-
mal hematocrits. Differences in hematocrit are one reason
why critically ill patients and neonatal populations with
low and high hematocrits may show biases between the
two methods, and why validation of POCT in the intended
patient population is so important.
There are a variety of factors that can affect POCT
differently from laboratory methods. These factors must
be considered when implementing POCT or when inter-
preting the POCT literature. A device that works well on
one medical unit and patient population may show differ-
ent results in another patient population due to medica-
tion, diet, or operational differences between the two
sites. Validation of POCT devices by staff operators on
the intended patient populations will most likely uncover
interferences and other potential problems before imple-
mentation and routine use of a device. When environmen-
tal effects or unexpected interferences are discovered,
practices can be changed to control against test exposure
or alternative devices can be selected, which do not expe-
rience the same interferences.
The potential for interference, operator, and environ-
mental effects sets POCT apart from central laboratory
methods. Results from POCT should be clearly separated
from central laboratory test results in the patient’s chart.
As hospitals move toward electronic records, POCT result
interfaces should distinguish the source of the test result
for the ordering clinician. Clinical systems have the abil-
ity to overlay test results, so all glucose values or sodium
values, for instance, can be viewed and trended together.
From the clinician’s perspective, seeing more information
together on a computer screen saves time and prevents
scrolling through result spreadsheets and multiple mouse
clicks. However, differences in methodologies between
POCT and central laboratory will cause results to jump
around when plotted or trended together. This can lead to
clinical confusion and chasing results where treatment is
based on one result, but the next result comes back too
low. Based on this, therapy is readjusted; then the next
result is too high, so therapy is adjusted again. Combining
results from multiple methods can lead to such clinically
confusing trends, overtreatment, and frequent changes in
treatment that would not occur if the individual methods
were separated in the patient’s medical record.
Other distinctions that should be identified in the med-
ical record are calculated and measured results. Some
blood gas analyzers measure hematocrit by conductivity
and calculate hemoglobin by a common conversion
(hemoglobin 5 hematocrit/3), while other analyzers mea-
sure hemoglobin spectrophotometrically and calculate
hematocrit. Conductivity hematocrit is sensitive to protein
Point-of-care testing Chapter | 19 333
concentration and can be biased in surgical and trauma
patients who receive transfusions and volume replace-
ment. So POCT results for hemoglobin and hematocrit
should specify not only that result was performed point-
of-care, but whether the result was calculated or mea-
sured. These are only a few of the interface challenges to
consider because of the unique method differences and
biases that can occur with POCT in some patient
populations.
Risk management
POCT systems are not perfect. All devices have limita-
tions. When used outside manufacturer recommendations
or used improperly, incorrect results can be generated.
Errors can be more likely with POCT because of the num-
ber of operators involved, the volume of tests being con-
ducted, and the various locations where testing is
performed. POCT is often delegated to the lowest level of
staff who have minimal training and experience. Staff
shortcuts, differences in operator technique, and failure to
appreciate patient and preanalytic factors can all compro-
mise test quality. POCT is chosen over laboratory testing,
because it is rapid and convenient. POCT can be per-
formed at a variety of locations with the opportunity for
the device and the reagents to be exposed to heat, cold,
and humidity. The number of operators, tests, and loca-
tions multiplies the complexity of managing the testing
process in a quality manner. Environmental exposure,
sample, and operator errors can all lead to incorrect
results.
Risk management can reduce errors. Manufacturers
employ risk management when developing new methods
in order to document that common hazards or the poten-
tial for errors have been addressed by the device engineer-
ing and that the limitations have been outlined in the
package insert and instructions for use. The FDA consid-
ers the manufacturer risk management plan when review-
ing the device for market approval. This plan outlines
how the device is intended to be used (use-case scenario)
and how the manufacturer addresses or detects potential
misuse. With POCT, a device may be brought to the
patient’s bedside for testing, or alternatively a sample
may be collected and brought to a device in a spare utility
room on the nursing unit for testing. Moving a sample
away from the patient presents the potential to mix-up
samples with other patients tested in that utility room,
unless the sample is labeled appropriately. These two use-
case scenarios present different opportunities for particu-
lar errors, such as specimen mix-up. Risk management
examines each step in the testing process for weaknesses
where errors may occur and defines actions that may be
required to reduce, prevent, or detect those errors before a
result is released and action is taken by clinicians. So
334 Contemporary Practice in Clinical Chemistry
laboratories can learn to reduce their chance for test errors
by adopting industrial risk management principles.
Testing liquid QC specimens in a manner like patient
specimens have historically been utilized to prove the
ability of a test system to achieve a test result with the
expected level of quality; however, liquid controls have
limitations. With POCT, analyzing a QC sample con-
sumes a single-use test kit, and there is no guarantee that
the next kit will perform comparably. Based on this, man-
ufacturers have developed a number of control processes
engineered into the test or actions required to be per-
formed by the laboratory to achieve quality results.
Newer devices have clot and bubble detection, volume
detection to ensure adequate sample was applied, and
internal controls to prove the viability of reagents such as
internal controls on pregnancy, HIV, and drug tests.
Reagents are being shipped with a temperature monitor to
ensure the package has not been exposed to heat or cold
temperatures outside of manufacturer specifications dur-
ing shipping. Staff are expected to check the temperature
monitor on receipt of each shipment and verify accept-
ability before attempting to place the kits in use for
patient testing. Each POCT device and test kit is unique
and may present different opportunities for error depend-
ing on how the device is used by the consumer. Applying
risk management to trace the sample through the testing
process can reveal hazards or potential sources for error
and the actions that are required to prevent and detect
those errors. CLSI has published a guideline for assessing
the risk of errors from implementing unit use testing
devices, titled “Quality Management for Unit-Use
Testing” [18]. This document advocates the use of an
error matrix to list and prioritize the frequency and sever-
ity of potential errors associated with testing devices. This
guideline also emphasizes a shared responsibility between
the manufacturer and the consumer of the testing device
in developing appropriate control strategies to manage
errors. Another CLSI document, EP 23-A, titled
“Laboratory Quality Control Based on Risk Management”
[19], outlines a strategy to develop an IQCP for the labo-
ratory test based on risk management. An IQCP basically
summarizes many of the quality activities a laboratory is
already doing in a more formal manner. The IQCP is dis-
cussed in further detail in Chapter 5, Quality control.
Manufacturers have been conducting risk assessments for
years and must submit their data for FDA review when
seeking market approval of new tests. CLSI EP23 and the
IQCP introduce these industrial risk management princi-
ples into the clinical laboratory.
Summary
POCT is an increasingly popular means of delivering fas-
ter test results closer to the patient. As the number of
devices and menu of tests expands, the POCT market can
be expected to grow. The major concern with POCT is
providing quality test results with multiple devices, at
dozens of sites by thousands of operators. Management of
POCT, therefore, requires organization. POCT manage-
ment can best be organized by forming a POCT commit-
tee to supervise new test requests and set policies,
standardizing and minimizing the number of devices,
planning implementation through validation of devices
and training of operators, and providing consistent labora-
tory oversight to comply with regulatory requirements.
POCT is a different method and may not be freely inter-
changeable with laboratory results in clinical protocols.
Each method has unique interferences, biases, and impre-
cision that can lead to disparate results in certain patient
populations. The potential for method differences stresses
the need to validate devices at the intended clinical sites
by using clinical staff operators to test typical patients
before the decision to implement a device for patient
care. Newer devices are computerized and can automati-
cally collect and transfer the test results and QC data nec-
essary to document regulatory compliance. Interfaces of
POCT results should distinguish POCT results from labo-
ratory results in order to prevent clinical confusion that
can occur from overlaying results with unique biases in
certain patient populations and clinical situations. Many
newer POCT devices also offer improvements in detect-
ing common errors through internal control processes.
Risk management offers a means for laboratory directors
to determine the required actions and optimal control
strategies to minimize risk of errors for any specific
device in their healthcare setting and use-case scenarios.
POCT has the potential to provide faster results and
improve patient outcomes through quicker therapeutic
intervention provided that the clinician understands the
method limitations and when to use the devices in patient
care appropriately. POCT is thus a complex system with
many factors to consider and manage to obtain optimal
benefits.
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336 Contemporary Practice in Clinical Chemistry

Self-assessment questions b. Stopping reimbursement from Medicare and Medicaid

c. Closing the laboratory or physician’s office perform-
1. What is the definition of point-of-care testing? ing testing.
a. Testing conducted close to the site of patient care d. All of the above
b. Bedside testing 7. POCT device connectivity and the POCT1 standard
c. Portable testing in an ambulance or helicopter are important for what reason(s)?
d. All of the above
a. Allows multiple devices to connect to a single data man-
2. Which of the following tests are available from POCT ager and share an interface with a laboratory or HIS
devices? b. Allows collection and review of data from multiple
a. Growth hormone sites
b. Dihydrotestosterone c. Facilitates implementation of new POCT devices
c. HIV antibody through plug-and-play connections
d. Renin d. All of the above

3. What are the advantages of POCT? 8. Limitations of POCT devices include which of the
following?
a. Larger sample
b. Faster turnaround time for test results a. Ability of physicians to rapidly treat patients
c. Less expensive than core lab testing b. Environmental and drug interferences with rapid
d. More precise than core lab instrumentation methods
c. Ease of use and training of the operator
4. Which regulations apply to POCT devices? d. Small sample volumes
a. Federal CLIA regulations 9. Which of the following is a QC process?
b. State law
c. Private accreditation agency standards like The Joint a. A whole blood control above the medical decision
Commission limit for a test
d. All of the above b. A colored disk to check the optics of a spectrophoto-
metric device
5. Which of the following are true? c. A separate control line that develops with each test on
a. POCT results can lead to wrong treatment, and care a pregnancy strip test
should be taken to guarantee quality. d. All of the above
b. POCT devices are so simple that they pose no risk to 10. What is risk management?
the patient if incorrectly performed or a wrong answer
is generated. a. A requirement for FDA approval of new devices
c. POCT results are used only for screening patients, and b. An industrial process for defining potential errors in
results are always confirmed by a lab method. the use of a device
d. Clinicians can purchase POCT devices from a local c. A means for clinical laboratories to prevent and detect
pharmacy without having to comply with laboratory errors
regulations if the tests are used only on their own d. All of the above
patients in an office practice.
6. The DHHS enforces CLIA standards in which way(s)?
a. Limiting the physician’s medical license to practice
Answers
1. d
2. c
3. b
4. d
5. a
6. b
7. d
8. b
9. d
10. d